TECHNICAL SOLUTIONS

CEP Support

Technical documentation support for Certificates of Suitability.

Document review and gap analysis to support the submission process.
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From brief to delivery

1

Research

Define the product and technical requirements.

2

Pre-formulation

Compatibility screening and physicochemical characterization.

3

Development

Formulation and process development.

4

Analytical validation

Analytical method development and validation.

5

Scale-up

Support progression from laboratory to pilot scale.

6

Process validation

Validation protocols and process optimization.

7

Technology transfer

Transfer dossiers, master batch records and stability data.

8

Commercial support

Manufacturing coordination and regulatory filing support.

YOUR NEXT STEP

Looking for a specific API, formulation or technical solution?

Share your product, quantity and documentation requirements. Let’s take the next step together.

Submit product requirement ↗